Reagents

ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Reagents
• ISE Reagents:
ISE Internal Standard, ISE Diluent, ISE Reference are the reagents located in
the ISE reagent compartment. A sensor detects the presence of a reagent bottle
and the ISE probe is equipped with a level detector which monitors the liquid
level. Please date the ISE bottles as you put them on the analyzer. ISE reagent
should be changed every two weeks and care must be taken not to spill or
splash these reagents during changeover.
o To Replace ISE IS and ISE DIL:
1. These reagents can be replaced while in operation with the top cover
closed.
2. Place new bottle in the empty position where the green light is lit up. If
there is already a standby bottle on board remove the empty bottle and
place a new bottle in the position.
3. When replacing ISE DIL simple replace and continue operation.
4. When replacing ISE IS, ISE must be calibrated followed by QC.
o To Replace ISE Reference:
1. Put module in standby.
2. Unlock and open top cover of module.
3. Attach dedicated cover over ISE reagents bottles. This step is very
important to prevent any contamination of the reagents.
4. Remove the tubing from the ISE Ref. bottle and unscrew the filter from
the end of the tubing.
5. Clean and rinse filter with deionized water by simple running DI water
through the filter. Dry off with a dry piece of gauze.
6. Screw the filter back on and place inside new reagent bottle (making
sure the tube touches the bottom).
7. Clean any spills or splashes.
8. Remove the protective dedicated cover.
9. Close top cover and lock it.
Cobas Reagents
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ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
10. After replacing ISE Reference bottle it is necessary to perform a
Reagent Prime. (See below for instructions)
o To Perform Reagent Prime:
1. From System Overview screen, select Reagent Preparing.
2. Choose Reagent Prime.
3. Deselect the modules you do not need by clicking on each one, the
selected module you want will be in white.
4. Choose Ref. in the ISE area.
5. Choose Execute.
6. The prime is complete when the analyzer returns to standby.
• 501 Reagent Cassettes:
The c501 module automatically unloads empty reagent cassettes to the
cassette disposal chute. It will not automatically unload the expired reagents.
This must be done manually when the instrument is in standby. 501 cassettes
can be loaded while the instrument is in operation.
1. There are two exceptions with the 501 reagents, Direct Bilirubin and
Gentamicin. These reagents must be made up manually.
2. Direct Bilirubin is a Roche reagent. It comes with a DBIL cassette,
therefore, when loaded on to the analyzer the analyzer knows what the
reagent pack is. See package insert for instructions on how to make up
the DBIL reagent.
3. Gentamicin is not a Roche reagent. It needs to be made up in a Multipack, therefore, when loaded on to the analyzer the analyzer has know
idea what is in that reagent pack. See package insert for instructions on
how to make up the GENT reagent. See below for how to load and
unload GENT reagent packs.
o To Load/Unload Gentamicin Multi Pack:
1. Must be in standby.
2. Dump the old reagent pack (there can only be 1 Gent.reagent on at a
time). Go to Reagent – Settings tab – select the 501 module from the
box in the upper left hand corner – select the Gentamicin reagent from
the reagent list – select Cassette unload – Dump – Execute. Remove the
cassette from the cassette disposal chute (located behind the left door of
the 501) and discard in a biohazard bucket to be discarded.
Cobas Reagents
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ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
3. Once the reagent pack has been prepared write the date and name of
reagent on the cassette.
4. Select Reagent – Settings tab – Open Channel – select GENTA – select
Reserve button – hit OK. Load on the reagent pack like any 501
cassette (See below for instructions).
o To Load 501 Reagent Cassettes:
1. Can occur while in operation or in standby.
2. Fold the cassette table downward to get to the cassette loading port.
(White flip door at the front of the 501 module.)
3. Place the reagent pack in the loading port (small square opening once
door is flipped down.) with the barcode label facing toward the right.
4. Slide the reagent pack all the way into the loading port until you feel
resistance. Instrument will do the rest.
o To Unload 501 Reagent Cassettes:
1. Module must be in standby.
2. From overview screen, go to Reagents – Settings tab.
3. Select the 501 module.
4. Select the position of the reagent cassette that is to be unloaded.
5. Choose Cassette Unloading.
6. Choose either Unload (this will send cassette to loading port and can be
reused), or Dump (this will send cassette to the cassette disposal chute
located behind the large door to the right and bottom of the 501 module
and must be discarded).
7. Open the large door at the front of the 501 to remove reagent packs
from the disposal chute.
•
501 Auxiliary Reagents: (Refer to Quick Ref. Cards for more info.)
When replacing auxiliary reagent bottles, you have to manually reset the
software’s reagent volume count.
Cobas Reagents
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ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Product Name
Short Name Description
Location
Cell Wash Sol’n 1
Or NaOH-D
Cell Wash 1
Rinsing & cleaning
used reaction cells
1 large bottle
behind left front door
Cell Wash Sol’n 2
Or Acid Wash
Cell Wash 2
Rinsing & cleaning
reaction cells
1 large bottle
behind left front door
Multiclean
Multiclean
SMS/ Acid Wash
SMS
Hitergent
Hitergent
NaOH-D
NaOH-D
SMS
SMS
Sample probe wash
1 bottle of 70mL
Solution 1 NaOH-D
reaction disk area
Sample probe wash
1 bottle of 70mL
Solution 2 acid wash
reaction disk area
Surfactant for water bath,
1 bottle of 70mL
prevents algae & foam
reaction disk area
Detergent 1 for reagent probe 1 cassette
wash & cell wash
reagent rotor
Detergent 2 for reagent probe 1 cassette
wash & cell wash
reagent rotor
o To Replace Cell Wash 1 and/or 2 Detergent Bottle:
1. Put the module in standby.
2. Open the left front door to the 501 module.
3. Replace required reagent bottle and clean aspiration filter. Unscrew the
filter at the end of the tubing, run under DI water, dry with gauze, screw
the filter back on. (Reference C-88) Place the bottle in position, lower
the tube with the filter attached in to the bottle. Make sure the tubing
touches the bottom of the bottle.
4. Reset volume count under ~ Reagent – Status tab – Inventory Setting –
select the correct reagent that needs to be reset – choose Reagent
Volume Reset button – choose OK to confirm the reset.
o To Replace MultiClean, NaOHD, Hitergent:
1. Put module in standby.
2. Unlock and open top cover.
3. Replace required reagent bottle by removing the empty and placing a
full bottle in to place.
Cobas Reagents
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against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
4. Reset the volume count under Reagent – Status tab – Inventory Setting
– select the correct reagent that needs to be reset – choose Reagent
Volume Reset button – choose OK to confirm the reset.
o To Replace SMS:
1. The SMS on top of the 501 module is used when amphetamines are
being run. We do not run amphetamines, therefore, this bottle never
needs to be replaced. We leave an empty bottle in the position so that
other reagents do not get put in the wrong position.
• 601 Reagent Packs:
The principal reagent container for the Cobas e 601 module is the e pack. For
each e 601 application there is an individual Cobas e pack available which
must be loaded and unloaded manually.
o To Load/Unload a Cobas e Pack:
1. Put module in standby.
2. Lift off the lid of the reagent disk.
3. Reagent for the 601 must be taken out of the refrigerator at least 1 hour
prior to loading on analyzer, DO NOT MIX reagents.
4. Open all lids on the e pack and check that there are no bubbles, close
lids but do not snap shut. The gripper is not strong enough to open a
completely closed lid. Over time the part will ware. Leaving the lids
closed loosely will make it easier for the gripper to open and close the e
packs.
5. Place the required reagents in the reagent disk by correct orientation (e
pack will only fit one way). White faces the outside of the ring and
black faces the inside of the ring. There are some reagents that have
only one or two lids instead of three. They are color coordinated the
same way.
6. Close the reagent disk lid and turn handle to the lock position. A
reagent scan is activated, it will display Reagent Registration on top left
hand corner of the computer screen. The reagent overview window will
be updated.
Cobas Reagents
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against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
• 601 Auxiliary Reagents: (Refer to Quick Ref. Cards for more info.)
The e 601 module uses a light indicator to show when it is safe to replace a
reagent. Change reagents only when the green light is flashing. If an alarm
code appears indicating a particular reagent is getting low ignore the message
until the green light is flashing.
Product Name
Short Name
Pro Cell M
PC
Clean Cell M
PreClean M
Description
Location
Conditioning of electrodes, transport
Behind
of assay reaction mixture, washing of
front door
microbeads, signal generation.
CC
Cleaning of tubing system and
Behind
measuring cell after each measurement. front door Conditioning
of electrode.
PreClean
Remove potentially interfering substances Behind
before signal generation, required for
front door
only certain assays.
Probe Wash M
Probe Wash
Cleaning the reagent probe.
By rgt probe
SysClean
SysClean
Sodium hypochlorite solution
for cleaning of measuring cells.
Stored in
small fridge
o To Replace ProCell/CleanCell:
1. Module may be in operation or standby.
2. ProCell only: Before replacing, the lot number must be checked and
updated if necessary. If both lots are the same then simple replace as
per the following steps. If the lot number on the replacement bottle is
different then the lot number that is being replaced, the lot must be
updated. To do so, the instrument must be in Standby. Go to Reagent –
Status tab – select 601 module in the upper left hand corner – click on
ProCell in the lower right hand box – select the position that is being
updated
(1 or 2) – Inventory Settings button – in the appropriate
position (1 or 2) enter the new lot number – Execute.
3. Open the left front door of module e 601.
Cobas Reagents
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against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
4. Where you see the green flashing light, pull the aspiration tube up and
to the left to secure it on the respective notch.
5. Absorb the excess liquid with lint free gauze squares.
6. Remove the empty bottle (indicated by the flashing green light button),
and replace it with a full bottle ensuring that it is securely in place (the
bottle will only fit one way). DO NOT POOL left over reagent, discard
down the sink.
7. Lower the aspiration tube into the new bottle.
8. Press the green flashing button corresponding to the position in which
the new bottle has been placed. This informs the system that a new
bottle was loaded. The button will be illuminated indicating that this is
a standby bottle.
9. Close the front door of e 601.
o To Replace PreClean:
1. Module may be in operation.
2. Open the left front door to the e 601 module.
3. Remove the empty bottle on the door indicated with a green flashing
button.
4. Remove the cap with the hole from the empty bottle and place it on the
new bottle. Slide new full bottle securely into place. If the cap with the
hole breaks or goes missing simple place the new bottle on with the cap
placed on loosely.
5. Press the flashing green button corresponding to the position in which
the new bottle has been placed, this informs the system that a new
bottle has been loaded. The button will be illuminated indicating that
this is a standby bottle.
6. Close the door to the e 601.
o To Replace Probe Wash:
The 2 Probe Wash bottles, located on the 601 module near the reagent
probe, can simply be replaced as needed. The reagent probe is equipped
with a liquid level detector which senses the remaining volume.
1. Module must be in standby.
2. Remove the empty Probe Wash bottle.
3. Remove the cap from the new bottle.
Cobas Reagents
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against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
4. Place new bottle in its place.
5. The level is checked and the inventory is automatically updated.
• Replacing Consumables and Emptying Solid Waste:
o To Replace Assay Cups & Assay Tip Magazines on 601:
1. Instrument may be in operation or standby.
2. Only do this when the indicator light on the top of the magazine drawer
is ON – DO NOT open if light is flashing. A flashing light means that it
is about to operate.
3. Pull the drawer out on the right hand side of the module.
4. Remove the empty magazine trays.
5. Close the door securely.
6. Open the door in front of the drawer to load new magazine trays as
required. Close the door.
7. The level is checked and the inventory is automatically updated the next
time the analyzer changes the magazine.
o To Empty Solid Waste:
1. Instrument may be in operation or standby.
2. Only do this when one of the two green buttons to the right of the
magazine lifter is flashing.
3. Only do this when the indicator light on the top of the magazine drawer
is ON – DO NOT open if light is flashing. A flashing light means that it
is about to operate.
4. Pull out the drawer on the right hand side of the module fully.
5. Remove the waste container that the flashing light is indicating needs
replacement and place a new one into the position.
6. Close the drawer, ensuring it is fully closed.
7. Open the door in front of the drawer. Press the flashing green button
after you have changed the waste to update the system. DO NOT press
the green button under any other circumstances.
8. Close the door ensuring it is fully closed.
Cobas Reagents
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against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Cobas Reagents
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This is a CONTROLLED document. Any documents appearing in paper form are not controlled and should be checked
against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Cobas Reagents
Page 10 of 14
This is a CONTROLLED document. Any documents appearing in paper form are not controlled and should be checked
against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Cobas Reagents
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This is a CONTROLLED document. Any documents appearing in paper form are not controlled and should be checked
against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Cobas Reagents
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This is a CONTROLLED document. Any documents appearing in paper form are not controlled and should be checked
against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Cobas Reagents
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This is a CONTROLLED document. Any documents appearing in paper form are not controlled and should be checked
against the document on the server prior to use.
ANNAPOLIS VALLEY DISTRICT HEALTH AUTHORITY
LABORATORY SERVICES
Department: Chemistry
Site: VRH
Date Issued: February 2011
Date Revised:
Number: SOP # 2.011
Title: Cobas Reagents
Literature References:
1. COBAS 6000 analyzer series Operator’s manual, version 3.0
2. COBAS 6000 analyzer series Basic Operator’s Training Guide, version 4
Notes:
Related Documents:
Document #
Document Name
Approved by:
MEDICAL DIRECTOR
DIRECTOR OF
LABORATORY SERVICES
NAME & SIGNATURE
Dr B Jollymore
DATE
Anne Strong
Replaces: N/A
Revision History
Written by
Revised/reviewed by
Cathy Fraser MLT
Jessie Best MLT
Margaret Sweeney
Senior Technologist
February 2011
February 2011
Revised/reviewed by
Revised/reviewed by
Revised/reviewed by
DATE REMOVED FROM SERVICE:
Cobas Reagents
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